Duns Number:961027315
Device Description: 8 SGL Urine StripLeukocytesNitriteProteinpHBloodSpecific GravityKetonesGlucoseFor Urine
Catalog Number
UA8SGL
Brand Name
CARDINAL HEALTH
Version/Model Number
UA8SGL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
5529a41f-7b08-4688-8d8c-14782479d3a9
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2020
Package DI Number
50885380175570
Quantity per Package
10
Contains DI Package
20885380175579
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |